BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    Persona® Personalized Knee System

    K Number: K212129 · Decision Sep 28, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    910
    Applicant Total
    4
    Review Days
    82

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Persona® Personalized Knee System
    K Number
    K212129
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3560
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zimmer Switzerland Manufacturing GmbH
    Date Received
    July 8, 2021
    Decision Date
    September 28, 2021
    Product Code
    JWH
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JWH), ordered by most recent decision date.

    NovoKnee (SteriKnee)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Materialise TKA Guide System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EMPOWR Knee

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Freedom Infinia™ Total Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Freedom® Total Knee System – Titan PCK Components

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    View all

    Other Clearances by Zimmer Switzerland Manufacturing GmbH

    K Number Device Name
    K253749 Affixus® Natural Nail® Proximal Humeral System
    K241754 NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate
    K231114 Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System